OP0070 METHODS - A RANDOMIZED CONTROLLED TRIAL OF METHOTREXATE TO TREAT HAND OSTEOARTHRITIS WITH SYNOVITIS
Authors: Y. Wang, G. Jones, H. Keen, C. Hill, A. Wluka, J. Kasza, A. Teichtahl, R. O’sullivan, F. Cicuttini
Journal: Annals of the Rheumatic Diseases (2023)

<h3>Background</h3> Hand osteoarthritis (OA) with synovitis is a common clinically identifiable phenotype which is associated with pain and disease progression. Methotrexate is a low-cost, well-established and effective treatment for inflammatory arthritis with a well-described safety profile. A previous randomized controlled trial showed no superiority of 10 mg methotrexate over placebo in pain relief at 3 or 12 months in patients with erosive hand OA<sup>[1]</sup>. No study has examined methotrexate in hand OA with inflammatory phenotype. <h3>Objectives</h3> To examine whether methotrexate reduced pain and improved function over 6 months in patients with hand OA and synovitis. <h3>Methods</h3> In a multicentre, randomized, double-blind, placebo-controlled trial, patients with symptomatic hand OA and MRI-detected synovitis were recruited and randomly assigned in a 1:1 ratio to receive methotrexate 20 mg (n=50) or identical placebo (n=47) once weekly for 6 months. The primary outcome was pain reduction (assessed by 100mm visual analogue scale, VAS) at 6 months. Secondary outcomes included changes in physical function and quality of life assessed using Australian Canadian Osteoarthritis Hand Index (AUSCAN), Functional Index for Hand Osteoarthritis (FIHOA), Health Assessment Questionnaire (HAQ), and Michigan Hand Outcomes Questionnaire (MHQ). Adverse events were recorded. The primary analysis was by intention to treat, including all participants in their randomized groups. Mixed linear regression models were fit to continuous outcomes, adjusting for baseline values of outcome, sex and site, and the clustering of measurements within participants. <h3>Results</h3> Of 97 patients [mean age 61.4 (SD 6.7) years, 68 (70.1%) female], 82 (84.5%) provided the 6-month primary outcome. At 6 months, the methotrexate group had greater reduction in VAS pain (-15.2 vs -7.7, difference -9.9, 95% CI -19.3 to -0.6) (Figure 1), AUSCAN pain (-55.3 vs -13.5, diff -47.0, 95% CI -91.5 to -2.5) and stiffness (-14.5 vs -2.9, diff -11.4, 95% CI -20.8 to -2.0) than the placebo group (Table 1). The between-group differences were not clinically meaningful for change in AUSCAN function [-52.7 (-127.3 to 21.9)], FIHOA [-0.9 (-3.4 to 1.7)], HAQ [-0.0 (-0.2 to 0.2)], or MHQ [5.5 (-0.3 to 11.3)]. Incidence of adverse events was 62.0% in methotrexate and 59.6% in placebo group. <h3>Conclusion</h3> This study provides high-quality evidence for the effect of methotrexate (20 mg once weekly) on reducing pain and stiffness over 6 months in patients with hand OA and synovitis. The results have the potential to inform clinical practice guidelines for the management of hand OA with the inflammatory phenotype. <h3>Reference</h3> [1]Ferrero S, Wittoek R, Allado E, et al. Methotrexate treatment in hand osteoarthritis refractory to usual treatments: A randomised, double-blind, placebo-controlled trial. Semin Arthritis Rheum 2021;51:831-8 <h3>Acknowledgements:</h3> NIL. <h3>Disclosure of Interests</h3> None Declared.